Translational pediatrics · 2026
Ambroxol hydrochloride and clenbuterol hydrochloride oral solution versus ambroxol hydrochloride injection for pediatric lower respiratory tract infection with mucoid sputum: a multicenter, non-randomized observational study in China.
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Chen Chunlei, Hu Bing, Liu Enmei, Ma Jinhai, Liu Changshan, Dong Xiaoyan, Zi Huifen, Hao Chuangli, Lin Rongjun, Zheng Xiangrong, Li Bingfei, Chen Fenhua, Fang Mei, Tian Weimin, Zhuo Zhiqiang, Zhao Deyu, Chen Zhimin, Zheng Yuejie, Zheng Jingyang, Yin Yong, Tang Qiuyu, Wu Liqun, Gu Li, Wu Jinzhun, He Liyi, Ai Tao, Liu Hanmin, Han Zhiying, Mo Yunbo, Tian Zhiliang, Lu Quan, Zou Yingxue
Аннотация
BACKGROUND: Mucoid sputum is common in pediatric patients with lower respiratory tract infection (LRTI) and can exacerbate cough, contribute to difficulty in expectoration and dyspnea, and even cause suffocation. Although ambroxol hydrochloride and clenbuterol hydrochloride oral solution [AHCHOS (or Yitanjing)] is widely used in pediatric practice, high-quality real-world evidence comparing it with conventional expectorant therapies such as ambroxol hydrochloride injection (AHI) remains limited. This study aimed to investigate the efficacy and safety of AHCHOS in pediatric patients with LRTI complicated with mucoid sputum.
METHODS: This multicenter, non-randomized observational study included 407 hospitalized pediatric patients with LRTI complicated by mucoid sputum across 30 institutions in China. Patients received AHCHOS (n=254) or AHI (n=153) based on clinical judgment and guardian preference. Inclusion criteria comprised age ≤14 years, confirmed LRTI diagnosis, and clinically significant sputum symptoms. Respiratory symptoms were assessed using a composite symptom score and a visual analog scale (VAS) at baseline and Day 7. Safety was evaluated through routine clinical monitoring, including vital signs, physical examination, and laboratory assessments.
RESULTS: The baseline features, including family history of respiratory disease (P<0.001) and type of the episode (P=0.02), differed between groups. The decline in total respiratory symptom score was greater in the AHCHOS group than in the AHI group at D7 (-4.35±2.25 vs. -3.56±1.89; P<0.001), as was the decrease in corresponding percentage (-77%±30% vs. -65%±28%; P<0.001). Regarding subscales, the decrease in cough (P<0.001), sputum amount (P=0.03), and wheezing rale (P=0.008) scores was significantly greater in the AHCHOS group than in the AHI group at D7, but the expectoration difficulty score was not (P=0.90). Meanwhile, the decrease in VAS score for self-reported symptom severity was greater in the AHCHOS group than in the AHI group at D7 (-4.12±2.04 vs. -3.51±1.78; P=0.006). Moreover, no adverse reactions were reported in either group.
CONCLUSIONS: AHCHOS was associated with improved respiratory symptom outcomes and was well tolerated in pediatric patients with LRTI complicated by mucoid sputum.
METHODS: This multicenter, non-randomized observational study included 407 hospitalized pediatric patients with LRTI complicated by mucoid sputum across 30 institutions in China. Patients received AHCHOS (n=254) or AHI (n=153) based on clinical judgment and guardian preference. Inclusion criteria comprised age ≤14 years, confirmed LRTI diagnosis, and clinically significant sputum symptoms. Respiratory symptoms were assessed using a composite symptom score and a visual analog scale (VAS) at baseline and Day 7. Safety was evaluated through routine clinical monitoring, including vital signs, physical examination, and laboratory assessments.
RESULTS: The baseline features, including family history of respiratory disease (P<0.001) and type of the episode (P=0.02), differed between groups. The decline in total respiratory symptom score was greater in the AHCHOS group than in the AHI group at D7 (-4.35±2.25 vs. -3.56±1.89; P<0.001), as was the decrease in corresponding percentage (-77%±30% vs. -65%±28%; P<0.001). Regarding subscales, the decrease in cough (P<0.001), sputum amount (P=0.03), and wheezing rale (P=0.008) scores was significantly greater in the AHCHOS group than in the AHI group at D7, but the expectoration difficulty score was not (P=0.90). Meanwhile, the decrease in VAS score for self-reported symptom severity was greater in the AHCHOS group than in the AHI group at D7 (-4.12±2.04 vs. -3.51±1.78; P=0.006). Moreover, no adverse reactions were reported in either group.
CONCLUSIONS: AHCHOS was associated with improved respiratory symptom outcomes and was well tolerated in pediatric patients with LRTI complicated by mucoid sputum.